MicroRNA Profile and Erenumab Treatment

May 26, 2024 updated by: Simona Sacco, University of L'Aquila

MicroRNA Profile in Women With Migraine Before and After Treatment With Erenumab

Erenumab, a monoclonal antibody acting on the calcitonin gene-related peptide (CGRP) receptor, is an effective and safe migraine-specific preventive drug. The use of migraine-specific preventive drugs paves the way for a novel method to study migraine pathogenesis. Migraine is a complex disorder with several genetic and epigenetic influence, including that of microRNA. Several microRNAs, including those of inflammation and of endothelial function, have high expression levels in subjects with migraine; however, the findings of the available studies are insufficient to provide epigenetic biomarkers for migraine. Besides, little evidence is available on the role of migraine preventive treatments in the expression of microRNA. The study aims at evaluating the expression profiles of microRNAs before and after erenumab treatment prescribed according to clinical indication. The study will include women with episodic or chronic migraine treated with erenumab 140 mg monthly according to the Summary of Product Characteristics and local reimbursement criteria. The study will compare the expression profile of microRNAs in women with episodic and chronic migraine; besides, it will investigate differences in migraine-associated microRNA expression according to age, migraine characteristics, pain intensity, response to erenumab, migraine-related impact and disability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • L'Aquila, Italy, 67100
        • University of L'Aquila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged 25 to 50 years
  • Chronic or episodic migraine with or without aura diagnosed according to the International Classification of Headache Disorders - 3rd edition
  • Receiving a first prescription of erenumab for migraine prevention according to the Summary of Product Characteristics and local reimbursement criteria
  • At least 1 year from migraine onset
  • Provided informed consent

Exclusion Criteria:

  • Headache other than migraine
  • Prior exposure to erenumab or other monoclonal antibodies targeting CGRP or its receptor
  • Use of any migraine preventive treatment in the last 60 days or 5 half-lives or 4 months if ever treated with botulinum toxin A
  • Pregnant or nursing
  • Body Mass Index <18 or >30 Kg/m2
  • Heavy smoking (more than 20 cigarettes per day)
  • Myocardial infarction, stroke, transient ischemic attack, unstable angina, or coronary artery bypass surgery or other revascularization procedures within 12 months prior to first visit
  • Illicit drug abuse
  • Major psychiatric disorders
  • Infective or inflammatory diseases
  • Any chronic medication prescribed for indications different from migraine within 60 days before study initiation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Episodic or chronic migraine
Women starting treatment with erenumab according to clinical indication
Genetic: Blood sampling for microRNA testing
Blood samples will be collected and analyzed for the microRNA profile by means of microfluidic cards

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fold changes in microRNA serum concentration - Episodic migraine
Time Frame: 3 months per each patient
Relative quantification of circulating microRNAs expression changes in women with episodic migraine after a 3-month treatment with erenumab with respect to pre-treatment. Data will be obtained by real-time polymerase chain reaction on microfluidic cards. Details on tested microRNAs are provided at the following link: https://assets.thermofisher.com/TFS-Assets/GSD/Reference-Materials/tac-advanced-miRNA-assay-list.xlsx
3 months per each patient
Fold changes in microRNA serum concentration - Chronic migraine
Time Frame: 3 months per each patient
Relative quantification of circulating microRNAs expression changes in women with chronic migraine after a 3-month treatment with erenumab with respect to pre-treatment. Data will be obtained by real-time polymerase chain reaction on microfluidic cards. Details on tested microRNAs are provided at the following link: https://assets.thermofisher.com/TFS-Assets/GSD/Reference-Materials/tac-advanced-miRNA-assay-list.xlsx
3 months per each patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline comparison between episodic and chronic migraine
Time Frame: Baseline
Relative quantification of microRNA expression levels at baseline in women with chronic compared with episodic migraine. Data will be obtained by real-time polymerase chain reaction on microfluidic cards. Details on tested microRNAs are provided at the following link: https://assets.thermofisher.com/TFS-Assets/GSD/Reference-Materials/tac-advanced-miRNA-assay-list.xlsx
Baseline
Subgroup analyses
Time Frame: 3 months per each patient
Subgroup analyses of patients stratified according to age, migraine characteristics, response to erenumab, and migraine-related impact and disability. Data will be obtained by real-time polymerase chain reaction on microfluidic cards. Details on tested microRNAs are provided at the following link: https://assets.thermofisher.com/TFS-Assets/GSD/Reference-Materials/tac-advanced-miRNA-assay-list.xlsx
3 months per each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Collaborators

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 26, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMG334AIT05T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine

Clinical Trials on Blood sampling for microRNA testing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe